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Combination Product Consultant - Chimera Consulting North America LLC

Chimera Consulting provides technical, regulatory affairs, quality assurance, compliance consulting services and training to large and small companies that develop, manufacture and market drugs, biologics, medical devices, and in particular combination products such as drug delivery systems and medicated devices. Michael Gross, Ph.D., RAC is the Principal Consultant of Chimera Consulting North America LLC and … Continue reading Combination Product Consultant →

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Michael Gross

1532 K●●●●●●Street

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1.21●●●●6028
mi●●●●●●●●●●●●●●●●●●@gmail.com

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Combination Product Consultant - Chimera Consulting North America LLC | chimeraconsultingna.com Reviews
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Chimera Consulting provides technical, regulatory affairs, quality assurance, compliance consulting services and training to large and small companies that develop, manufacture and market drugs, biologics, medical devices, and in particular combination products such as drug delivery systems and medicated devices. Michael Gross, Ph.D., RAC is the Principal Consultant of Chimera Consulting North America LLC and &hellip; Continue reading Combination Product Consultant &rarr;
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Combination Product Consultant - Chimera Consulting North America LLC | chimeraconsultingna.com Reviews

https://chimeraconsultingna.com

Chimera Consulting provides technical, regulatory affairs, quality assurance, compliance consulting services and training to large and small companies that develop, manufacture and market drugs, biologics, medical devices, and in particular combination products such as drug delivery systems and medicated devices. Michael Gross, Ph.D., RAC is the Principal Consultant of Chimera Consulting North America LLC and &hellip; Continue reading Combination Product Consultant &rarr;

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About Chimera Consulting North America LLC - Chimera Consulting North America LLC

http://chimeraconsultingna.com/about-chimera-consulting-north-america-llc

Chimera Consulting North America LLC. About Chimera Consulting North America LLC. To efficiently develop, manufacture and market medical products, companies need regulatory process predictability. Since the establishment of FDA’s Office of Combination Products progress has been made in clarifying how FDA regulates combination products. This has been accomplished through the promulgation of regulations, guidance documents and the posting concept papers on OCP’s website. Human Factors Studies and Related C...

2

Compliance - Chimera Consulting North America LLC

http://chimeraconsultingna.com/compliance

Chimera Consulting North America LLC. Chimera assists manufacturers in preparing for FDA inspections through mock-auditing and gap assessments and Chimera can assist manufacturing operations and site quality assurance functions, either behind the scenes or in a liaison role, during FDA inspections. Analysis: Human Factors Studies and Related Clinical Study Considerations in Combination Product Design and Development: Draft Guidance for Industry and FDA Staff. ECTD Technical Conformance Guide. Date tbd: C...

3

Training - Chimera Consulting North America LLC

http://chimeraconsultingna.com/training

Chimera Consulting North America LLC. Visit the Combination Product Training Institute website. Training programs for large groups can be held lecture hall or class room format and for small groups these can be held in informal settings around a conference table. One, two and three day standardized trainings and customized in-house workshops are available. Standardized training programs are offered on the following topics:. Marketing applications and labeling: format and content; CTD. Technical Developme...

4

Case Studies - Chimera Consulting North America LLC

http://chimeraconsultingna.com/case-studies

Chimera Consulting North America LLC. The following case studies listed on the right column. Are brief examples of combination product problems for which Chimera Consulting has provided assistance to clients. To assure confidentiality the examples are stated in general terms and the solutions are not provided. Artificial organ quality system. Biologic-device delivery device switch. Biologic-device reconstitution and delivery device stability. Biosimilar with Delivery Device. Drug delivery device selection.

5

Qualifications - Chimera Consulting North America LLC

http://chimeraconsultingna.com/qualifications

Chimera Consulting North America LLC. Chimera Consulting North America LLC. Michael has worked hands-on with a variety of drug delivery systems, infusion pumps, reconstitution systems, catheter flush solutions, surgical kits, medicated devices, computer controlled devices and drug/laser combinations for photodynamic therapy. He understands complex combination product development and regulatory issues. He is experienced in pre-clinical, clinical, pharmaceutics, quality, labeling, submissions and p...And i...

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Chimera Consulting North America LLC. Chimera Consulting provides technical, regulatory affairs, quality assurance, compliance consulting services and training to large and small companies that develop, manufacture and market drugs, biologics, medical devices, and in particular combination products such as drug delivery systems and medicated devices. Michael Gross, Ph.D., RAC. Final Guidance: Current Good Manufacturing Practice for Combination Products. ECTD Technical Conformance Guide. Incorporating Med...

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